IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 5: software development process – IEC 62304:2015 Medical Device Software Lifecycle Processes

IEC 62304:2015 Medical Device Software Lifecycle Processes 5.8.7: Archive software

What does 5.8.7 require?

The medical device software product and its configuration items, and the documentation, are archived for at least the longer of the software's lifetime as the manufacturer defines it or the time regulation specifies. Applies to classes A, B and C.

Maintained by Gerard BlokdykControl text last updated

Other controls in Clause 5: software development process – IEC 62304:2015 Medical Device Software Lifecycle Processes

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.